FDA grants study of Abiomed heart device

Cardiac medical device maker Abiomed Inc. has won conditional approval from the U.S. Food and Drug Administration for a pilot study to test its Impella 2.5 device reducing heart muscle damage in patients with ST-elevation myocardial infarction (STEMI).

The study, called MINI-AMI, will look at whether using the Impella 2.5 heart pump for 24 hours after percutaneous intervention helps to reduce the blockage of blood flow, as compared to standard procedures post-percutaneous intervention.